Acorda Therapeutics, a biotechnology company, has enrolled the first patient in an Ampyra (dalfampridine) proof-of-concept study in patients with post-stroke deficits.
The study, expected to include approximately 66 people, is designed to evaluate the safety and tolerability of Ampyra in people with stable post-stroke deficits after an ischemic stroke.
Acorda Therapeutics president and CEO Ron Cohen said the long-term functional deficits that result from a stroke can severely impact the independence and lives of stroke survivors and their caregivers.
"There are no medications currently indicated to treat the chronic neurological deficits associated with strokes," Cohen added.
"Preclinical data have shown that dalfampridine can improve functional deficits resulting from ischemic stroke, providing a strong basis for this first clinical trial in people with post-stroke deficits."
People who have experienced an ischemic stroke at least six months prior to enrolment, by which time the deficits are generally stable, will be included in the study.
Changes in walking speed, upper and lower extremity motor and sensory function, manual dexterity, assessment of functional independence in performing activities of daily living, and clinician and subject global impressions of general improvement are the exploratory efficacy outcome measures.
The company anticipates announcing initial study results in early 2013.
Ampyra is a potassium channel blocker currently approved in the US as a treatment to improve walking in patients with multiple sclerosis.
Ampyra is known as prolonged, modified, or sustained-release fampridine (Fampyra) in some countries outside the US.